drugset / Trial / NCT06532630
Anti-CD19-CAR-T Cells in Subjects With Relapsed/Refractory B Cell Malignancies
Phase 0
Recruiting
9 enrolled
Shanghai First Song Biotechnology Co., LTD
The First Affiliated Hospital of Anhui Medical University · collab
NaSingle-groupOpen-labelTreatment
Summary
This is a single-center, single-arm, open-label, exploratory study to determine the safety, tolerability, feasibility, and preliminary anti-tumor activity of anti-CD19-CAR-T cells in subjects with relapsed/refractory (r/r) B-cell malignancies. This study plans to enroll patients with relapsed/refractory CD19-positive B-cell malignancies, who will receive a single infusion of anti-CD19-CAR-T cells after screening, PBMC collection, and lymphodepleting chemotherapy.
Timeline
- Start
- 2023-08-24
- Primary completion
- 2025-09-01
- Completion
- 2026-09-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | anti-CD19 CAR-T cells | Cell therapy | — | Intravenous |
| Background | Cyclophosphamide | Other / unclassified | 250 mg/m2 | Intravenous |
| Background | Fludarabine | Small molecule | 25 mg/m2 | Intravenous |